cetirizine hydrochloride

Generic: cetirizine hydrochloride

Labeler: granules usa, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride
Generic Name cetirizine hydrochloride
Labeler granules usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
Granules USA, Inc.

Identifiers & Regulatory

Product NDC 69848-006
Product ID 69848-006_468e40c3-a669-29bd-e063-6394a90a8812
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209274
Listing Expiration 2026-12-31
Marketing Start 2021-06-30

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69848006
Hyphenated Format 69848-006

Supplemental Identifiers

RxCUI
1014678
UPC
0813874020438
UNII
64O047KTOA

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name cetirizine hydrochloride (source: ndc)
Generic Name cetirizine hydrochloride (source: ndc)
Application Number ANDA209274 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (69848-006-09)
source: ndc

Packages (1)

69848-006-09 90 TABLET in 1 BOTTLE (69848-006-09)

Ingredients (1)

cetirizine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Cetirizine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "468e40c3-a669-29bd-e063-6394a90a8812", "openfda": {"upc": ["0813874020438"], "unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["c8d711cd-7214-c7d5-e053-2995a90a6b67"], "manufacturer_name": ["Granules USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (69848-006-09)", "package_ndc": "69848-006-09", "marketing_start_date": "20210630"}], "brand_name": "Cetirizine Hydrochloride", "product_id": "69848-006_468e40c3-a669-29bd-e063-6394a90a8812", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "69848-006", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Granules USA, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine Hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA209274", "marketing_category": "ANDA", "marketing_start_date": "20210630", "listing_expiration_date": "20261231"}